Table 4 Guidelines for management of adverse reactions associated with trifluridine/tipiracil

• Absolute neutrophil count < 0.5 × 10⁹/L

• Interrupt dosing until absolute neutrophil count ≥1.5 × 10⁹/L

• Platelet count < 50 × 109/L

• Interrupt dosing until platelet count ≥75 × 10⁹/L

• Febrile neutropenia

• Interrupt dosing until toxicity resolves to grade 1 or baseline.

• When resuming dosing, decrease the dose level by 5 mg/m²/dose from the previous dose level.

• Do not increase dose after it has been reduced.

• CTCAE v.5 grade 4 neutropenia (< 0.5 × 10⁹/L) or thrombocytopenia (< 25 × 10⁹/L) that results in more than one week’s delay in start of next cycle

• CTCAE v.5 non-haematologic grade 3 or grade 4 adverse reaction; except for grade nausea and/or vomiting controlled by antiemetic therapy or diarrhoea responsive to antidiarrhoeal medicinal products